NIH Grant Writing

1. NIH Grant Writing Richard P. Donahue, University of Buffalo

2. Assignment to an IRG • Cover letter requesting a specific study section. • Put keywords in title and abstract.

3. R01 Review Criteria • Is it novel? • Is it significant? • Approach* Outcome Measure* Exposure or main effect* Covariates* Analysis* Power • Investigators • Environment • Minority/Gender • Human Subjects

4. General Types of Grants • Clinical • Etiology • Prevention

5. R01 Review Criteria Significance Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

6. R01 Review Criteria Approach Are the conceptual framework, design (including composition of study population), methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

7. R01 Review Criteria Innovation Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

8. R01 Review Criteria Investigator Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? PLEASE DO NOT INCLUDE descriptive biographical information unless important to the evaluation of merit.

9. R01 Review Criteria Environment Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? PLEASE DO NOT INCLUDE description of available facilities or equipment unless important to the evaluation of merit.

10. R01 Review Criteria Overall Evaluation In one paragraph, briefly summarize the most important points of the Critique, addressing the strengths and weaknesses of the application in terms of the five review criteria. Recommended a score reflecting the overall impact of the project on the field, weighting the review criteria, as you feel appropriate for each application. An application does not need to be strong in all categories to be judged likely to have a major scientific impact and, thus, deserve a high merit rating. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward.

11. Notes Concerning Funding • Study Sections are advisory in nature - do not make funding decisions. • Funding is decided at the Institute level with Advisory Council approval. • Institutions do not have to fund in order of priority score. • “Portfolio Balance” - may go outside the priority score order to fund grants that address needed areas. • Study Sections - “Unscore” one-half of all R01 submissions - approximately a score of 2.8 or above. • Fellowship applications cannot be unscored (scored 1 to 5)

12. Types of Grants (1) • R03 - Analysis only. Limited in $ (50K) total Limited in years (2 years) • R21 - Support to investigators changing areas of research. Limited in $ (100K) total Limited in years (2 or 3 years) • R01 - Most investigator-initiated proposals. Average cost =300k/year (total) Years of support limited to 4 years (NHLBI)

13. Types of Grants (2) • R29 - FIRST AWARD No longer accepted • NRSA - Institutional Individual • K Series - Clinician Scientist

14. Reviewer’s Comments The following is a list (in no particular order) of aspects of grant applications on which reviewers make comments or with which they express concerns.

15. Reviewer’s Comments (cont’d) • Representativeness of study samples • Generalizability • duration of the study/timing/sequencing • Absence of timelines/organization charts/graphic depictions of study designs • Conceptual/empirical rationales for variable

16. Reviewer’s Comments (cont’d) • Statistical analyses/power analyses • Protection of human subjectsconsideration of physicians as subjectsavailability of draft or final informed consent formspecification of risks for each treatmentinclusion/exclusion criteria • Staffing (commensurate with scope of work; appropriate expertise at correct times); absence of justification

17. Reviewer’s Comments (cont’d) • Budget (contributed time; flat over life of project) • Developmental or demonstration projects (need evaluation component • Hypothesis-generating vs. hypothesis-testing designs • Quantification of assertions/unfounded assertions • Instruments (pre-testing, reliability, validity, psychometerics evaluations); draft of finals included in appendices?

18. Reviewer’s Comments (cont’d) • Roles of staff (organization chart often helpful) • Letters of support/commitment (need assurances of commitment/collaboration), “in kind” support • Outcomes measures clearly specified? • Representativeness of study sample (gender and ethnicity); statistical data presented? (absence of this information necessitates entering a code that will preclude timely funding) • Matching objectives/hypotheses/process

19. Reviewer’s Comments (cont’d) • Subject attrition, response rate, recruitment, incentives • Confounding/contamination considerations • Inclusion of relevant publications (appendix) • Comparison studies vs. descriptive studies (the former do better in review • Availability of preliminary data • Use of medical charts for accessing data (missing data, variability); factoring in time and effort required.

20. Reviewer’s Comments (cont’d) • Homogeneity in cultures and race; acculturation • Self-report/social desirability/recall bias/self-identification/self-selection • Limitations of study and how they will be handled • Clarification of use of various scales (why they are used/not used)

21. Reviewer’s Comments (cont’d) • Addressing research issues from multicultural/multidisciplinary perspective • Proposing too many activities within one application • Internal/external validity • Allocation on the timeline for data analysis and report writing • clear statement of hypotheses, focused appropriately

22. Reviewer’s Comments (cont’d) • Educational/reading levels of subects who must read instruments or participate in an intervention • Inappropriate, excessive use of jargon in the application • Matching study design to the questions posed • Clarifying the unit of analysis • Budget - make sure totals are correct in all columns • Absence of an appropriate comparison

23. Reviewer’s Comments (cont’d) • Adequate amount of data for characterizing research subjects • evidence of experience in management of large, multisite projects • time commitments of investigators (Other Support) • maintaining confidentiality of data (storage/handling) • tieing literature to hypothesis

24. Reviewer’s Comments (cont’d) • Translation/back translation (demonstrate understanding of the complexities of this effort for surveys • Use of advisory committees, executive committees to oversee large, complex, multisite, multi-investigator projects • Acknowledge temporal events, background noise

25. Reviewer’s Comments (cont’d) • Define endpoints clearly • use standard, appropriate English, have a disinterested colleague review for clarity and grammar; spell-check document

26. Agenda • Getting started • Sources of funding • Different types of grants: Examples • Elements in the receipt and review process • Elements in Writing a good application • Overview of budget process • Building a Multidisciplinary Team • Use of consultants - Letters of Support • Wrap up

27. Overview of Agenda • Grant Opportunities in Research Training, and Career Development • The Grant Application Process • Focusing and Packaging a Good Funding Idea • Receipt and Referral Process • Review Process

28. SubmitsApplication Allocates Funds How a Research Grant is Made Investigatorinitiates research ideas School or otherResearch Center National Institutes of Health ??? NIH Division ofResearch Grants assignsStudy Section & Institute Study Section evaluates forscientific merit Institute evaluates for Program Relevance Advisory Council recommends action Institute Director takesfinal actionfor NIH director Conducts research

29. Dual Review System for Grant Applications First Level of Review • Scientific Review Group • Provide initial scientific review of grant applications • Recommend appropriate level of support and duration of award Second Level of Review • Council • Assess quality of SRG review of grant application • Make recommendations to institute staff on funding • Evaluate program priorities and relevance • Advise on policy

30. Sample Application Number IndividualResearch Grant SerialNumber Amended 1 R01 NR 12345 01 A1 NationalInstituteofNursingResearch GrantSupportYear NewApplication

31. Streamlined Summary Statements • Critiques are unedited comments of individual reviewers prepared prior to the discussion. • Critiques do NOT reflect committee deliberations and conclusions.